Wearable Auscultation Device Validation in Children

Asthma Clinical Trial

Official title:

Wearable Auscultation Device Validation in Children

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06112080
• Other study ID #: SL-LC01
• Status: Recruiting
• Start date: August 7, 2023
• Est. completion date: July 2024

Study information

• Verified date: November 2023
• Source: Strados Labs, Inc.
• Contact: Devan Parson
• Phone: 1-888-STRADOS
• Email: devan[@]stradoslabs.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This observational clinical study is an evaluation of a diagnostic tool through comparison. Similar to a validation study, the output of the RESP device will be compared to physician auscultation, surrogated by having an attending pulmonologist listen to blinded recordings.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 138
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Gender: All
• Age group: 4 Years to 17 Years

Eligibility

Inclusion Criteria:

• Any child aged 4-17 years of age
• Admitted to Lurie Children's Hospital or the Emergency Department at Lurie
• Normal breath sounds cohort: (16 patients ages 4-10, 16 patients ages 11-17)
• Admitted for a non-respiratory complaint
• Normal breath sounds on screening examination
• Wheeze cohort: (53 patients ages 4-10, 53 patients ages 11-17)
• Admitted for pathologic process that may lead to wheezing (e.g., asthma)
• Presence of wheeze on screening examination

Exclusion Criteria:

• Children less than age 4, adults (age 18 and above)
• Patients in the ambulatory setting
• Unable to provide consent
• Intubated patients
• Unstable disease posing a threat to life
• Adhesive allergy

Related Conditions & MeSH terms

• Asthma
• Asthma in Children
• Pediatric Asthma
• Respiratory Sounds
• Wheezing

Intervention

Device:
• RESP™ Biosensor
The RESP™ Biosensor will be placed on all participants for immediate capture and comparison of lung sounds.

Locations

Country	Name	City	State
United States	Lurie Children's Hospital of Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Strados Labs, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare the output of the RESP Biosensor System to breath sound interpretation of an attending physician via collected recordings from stethoscope and completion of a comparison questionnaire	PI will compare Strados RESP portal output with concurrent recordings collected via Littmann 300 Stethoscope. A questionnaire will be used to record and determine similarities and differences between RESP output and Littmann output, ultimately validating the intended use. Spectrographic data and audio recordings obtained via auscultation will be collected respectively by the RESP device and a separate recording stethoscope (Littman CORE Digital Stethoscope) simultaneously. Demographic and clinical data will be collected and stored in REDcap.	12 months
Secondary	Tolerability and usability assessed utilizing The System Usibility Scale to evaluate attitudes towards the use and tolerance of the device by patients and caregivers	Assess the tolerability and usability of the Strados device by patients and caregivers utilizing the System Usability Scale will be used to evaluate subjects and caregivers attitudes towards the use and tolerance of the device. The System Usability Scale is a validated tool for evaluation of the usability and tolerability of a device or system by users. Then, subjects and caregivers will engage in a recorded interview using talk-aloud feedback. Recorded data will be transcribed and evaluated through quality analysis	12 months